Pfizer recalls 2 batches of Duavive

The MHRA has announced that Pfizer is recalling two batches of Duavive, its oestrogen replacement product, as a result of concerns raised about faulty packaging. The MHRA said that during the manufacturer’s stability studies “an evaluation of the foil laminate pouch identified oxygen levels above the specified limits, resulting in lower dissolution results for bazedoxifene acetate.”

The MHRA went on to explain that batches AH1573 (exp. August 2021) and W96114 (exp. September 2020) of 28-size packs of Duavive 0.45mg/20mg modified release tablets are to be recalled as a precautionary measure, and any remaining stock of these batches should be quarantined and returned to Pfizer for reimbursement.